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Indicated for use in fragmentation of urinary calculi and soft tissue applications. The Cook® Odyssey Holmium Laser System is indicated for use in Urinary, Gastroenterology, Pulmonary, Gynecology, and General Surgery procedures where fragmentation of stones and soft tissue incision, hemostasis, vaporization and ablation are indicated.

The Cook® Odyssey Holmium Laser System is used in fragmentation of urinary calculi and soft tissue applications. The Cook® Odyssey Holmium Laser System is a pulsed holmium YAG laser emitting laser radiation at 2100 nm with a 30 Watt maximum average power. The normal wavelength is strongly absorbed by water for tissue ablation with minimal lateral thermal damage. In the case of laser lithotripsy, laser energy vaporizes water in the calculus causing it to crack into small enough particles to pass easily. The system is a completely enclosed transportable unit.

This submission is for a medical device (Cook® Odyssey Holmium Laser System) and focuses on substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria through a clinical study involving AI or human reader assessment. Therefore, much of the requested information (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) is not applicable or cannot be extracted from the provided text.

Here is the information that can be gleaned from the provided text, primarily focusing on the regulatory assertion of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. The submission describes a regulatory pathway based on substantial equivalence, not a clinical trial with a specific test set of patient data. The "Test Data" mentioned refers to engineering and bench testing to demonstrate compliance with standards, not clinical performance data in human subjects for statistical analysis.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. This is not a study involving expert assessment of medical images or data from a test set. The "ground truth" here is the regulatory equivalence established through technical and functional comparisons to predicate devices.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used to evaluate the impact of AI on human reader performance, which is not relevant for this device's 510(k) submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a laser system, not an algorithm or AI product. Its performance is inherent to its physical operation, not an algorithm's standalone analysis.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the identified predicate devices (VersaPulse® Power Suite, Medilas H 20, Odyssey™ 30 Holmium Laser Systems). The Cook® Odyssey Holmium Laser System's performance and design were compared to these legally marketed devices to demonstrate substantial equivalence, rather than against a specific pathology or outcomes data from a clinical trial.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a training set as this is not an AI-based device and no machine learning model was developed or trained.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is mentioned.

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